A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
研究概览
简要总结
Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.
详细描述
Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old.
- •Man seeking fertility treatment.
- •Azoospermia confirmed in at least 2 semen analyses with centrifugation.
- •Testosterone <300 ng/dL and Bioavailable Testosterone<156 ng/dL.
排除标准
- •Presence of genetic disorders: Y chromosome deletions or abnormal karyotypes.
- •Luteinizing hormone (LH) >25 IU/mL.
- •Estradiol > 40 ng/dL.
- •Hypogonadotropic hypogonadism (LH <2 IU/mL and Follicle Stimulating Hormone (FSH) <1 IU/mL).
- •Obstructive azoospermia (FSH <7.6 IU/mL plus testicle longitudinally axis >4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy).
- •Clinical varicocele (palpable or visible in physical exam)
- •Previous history of cryptorchidism.
- •Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner >40 years or female factor infertility associated.
- •Contraindications to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.
研究组 & 干预措施
Clomiphene citrate
Clomiphene citrate 50 mg daily during 4-6 months
干预措施: Clomiphene (Drug)
Placebo
Placebo (1 pill daily) during 4-6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
时间窗: After four months of clomiphene treatment
Epigenetic modifications
时间窗: After four months of clomiphene treatment
次要结局
- Testosterone levels and Bioavailable Testosterone levels(After two weeks and four months with clomiphene treatment)
研究者
Dr. Craig Niederberger
Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine
University of Illinois at Chicago